Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
NCT07320560
Summary
This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are: * Does ablation of targets defined by non-invasive global mapping improve rates of acute atrial fibrillation termination? * Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation). Participants will: * Undergo a personalized catheter ablation approach employing both a non-invasive global mapping system and a conventional intracardiac mapping system * Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up * Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up
Eligibility
Inclusion Criteria: Ablation-naïve patients with: 1. Persistent AF planned for catheter ablation plus 2. Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml/m2 or LA area ≥20 cm2) Exclusion Criteria: * Previous cardiac ablation * Age \<18 years * Pregnancy or lactation * Previous stroke/TIA * Severe left ventricular dysfunction (LVEF \<35%) * Renal failure (GFR \<30 ml/min) * Dermal disease or hypersensitivity predisposing for skin irritation or exanthema
Conditions2
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NCT07320560